Bioclinica Safety & Regulatory Services

Bioclinica Safety & Regulatory Services offers specialized Pharmacovigilance, Regulatory Affairs and related IT services to global pharmaceutical organizations.Within Pharmacovigilance, we offer end-end case processing, aggregate reporting, signal detection/assessment, & safety call center services, to pharmaceutical organizations across the globe. Bioclinica also specializes in Pharmacovigilance (PV) as a Service (PVaaS) as well as a traditional on-premise model. With PVaaS, we manage all aspects of Pharmacovigilance from application management and hosting through to business process support, on behalf of some of the global biopharmaceutical organizations. Patient safety is our core objective and we have built highly efficient processes to achieve this. Bioclinica’s approach towards Pharmacovigilance is focused on operational excellence. Patient safety is our core objective and we have built highly efficient processes to achieve this. Starting with focused approach towards training and its effectiveness, robust quality and compliance processes, experienced Pharmacovigilance leadership team enabling efficient governance model, onshore Pharmacovigilance subject matter experts (SMEs) as engagement managers (EMs) closely integrated to Pharmacovigilance operations team and best in industry employee satisfaction and engagement processes leading to highly skilled and stable workforce.